MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The device was received.Additional medical/surgical intervention required.The surgeon had to keep pulling the trigger out of its stuck position each time.There was a surgical delay of 30 minutes.Device history lot: part # 03.501.080, lot # 9790420.Manufacturing site: (b)(4).Release to warehouse date: 31.Mar.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Investigation summary: we have forwarded the received information to sustaining engineering for investigation, find the statement below: the functional tests performed on the returned device, after its lubrication according to the surgical technique it shows that the device is fully functional as per its design intend.Therefore, the ¿not lubricated¿ condition of the returned device is identified as the root cause regarding the intra operative instrument mail function.No design related issue was identified on the returned device.This complaint is therefore closed by the product development as invalid.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6).It was reported that during a coronary artery bypass grafting surgery on (b)(6) 2019, the spring system of the application instrument for sternal zipfix was not working properly.The trigger got stuck every time the surgeon tried to pull it to apply tension to the sternal zipfix implant.The spring system was suspected to be the problem.The surgeon had to keep pulling the trigger out of its stuck position each time.There was a surgical delay of 30 minutes.The procedure was completed with steel wire.There was no adverse consequence to the patient.Concomitant device: unknown sternal zipfix (part # unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8668209
• MDR Text Key: 146974193
• Report Number: 8030965-2019-64895
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 9790420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention